• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name vinyl patient examination glove
510(k) Number K120584
Device Name POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
Original Applicant
WEALTH ON (JIANGSU) CO., LTD
5 carey st
pennington,  NJ  08534
Original Contact charles shen
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/27/2012
Decision Date 07/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-